PIPELINE PED-400-35 (UDI 00847536016026)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536016026), received between Dec 5, 2019 and Apr 25, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (3 reports).

12 other recalls cover devices cleared under the same FDA submission (P100018); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE COULDN'T BE PUSHED OUT OF THE MARKSMAN CATHETER DURING DELIVERY. THE DEVICES WERE REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. ANGIOGRAPHIC RESULTS POST PROCEDURE SHOWED SLOW STASIS OF BLOOD IN THE ANEURYSM. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE CAVERNOUS SINUS SEGMENT OF THE INTERNAL CAROTID ARTERY. THE MAX DIAMETER WAS 12MM, AND THE NECK DIAMETER WAS 5MM. THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE LANDING ZONE WAS 3.6MM DISTAL AND 4.0MM PROXIMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WHICH WAS 8MM IN DIAMETER. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PRU LEVEL WAS 1. ADDITIONAL INFORMATION RECEIVED REPORTED THE TIP OF THE CATHETER IS SLIGHTLY ACCORDION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14197930 ↗
• MalfunctionFeb 8, 2021Activation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11292596 ↗
• MalfunctionSep 30, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE MIDDLE SEGMENT OF THE PIPELINE FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE RIGHT VERTEBRAL ARTERY WITH A MAX DIAMETER OF 20 MM AND A 7 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE PHENOM 27 MICROCATHETER WAS PARKED DISTAL TO THE ANEURYSM. THE PIPELINE WAS THEN DELIVERED, AND DEPLOYMENT WAS PERFORMED. THE DISTAL END OPENED WELL, AND DEPLOYMENT CONTINUED TO COVER THE NECK OF THE ANEURYSM. HOWEVER, THE MIDDLE SEGMENT OF THE PIPELINE THEN FAILED TO OPEN. IT WAS NOTED THE DEVICE WAS NOT POSITIONED IN A BEND, MORE THAN 50% HAD BEEN DEPLOYED, RESHEATHING WAS DONE LESS THAN 3 TIMES, AND NO ADDITIONAL STEPS WERE TAKEN IN AN ATTEMPT TO OPEN THE DEVICE. THE PIPELINE WAS WITHDRAWN, AND ANOTHER PIPELINE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. POST-PROCEDURE ANGIOGRAPHY SHOWED STASIS INSIDE THE ANEURYSM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10607355 ↗
• MalfunctionDec 5, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 5MM, A 4MM NECK DIAMETER, AND A LANDING ZONE OF 3.7MM DISTAL AND 3.9MM PROXIMAL. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT AFTER THE MARKSMAN WAS IN PLACE, THE STENT WAS PUSHED IN PLACE, AND THE TIP SIDE WAS DIFFICULT TO OPEN. AFTER REPEATED ATTEMPTS. IT STILL COULDN'T BE OPENED. IT WAS NOTED ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE A MARKSMAN CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9416700 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P100018. One submission often covers many models, so check the product and lot details in each record.

• Z-1245-2025 · Jan 30, 2025 · Open, Classified
  Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PE
• Z-1246-2025 · Jan 30, 2025 · Open, Classified
  Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PE
• Z-2402-2021 · Jul 13, 2021 · Open, Classified
  Pipeline Flex Embolization Device
• Z-2403-2021 · Jul 13, 2021 · Open, Classified
  EV3 Pipeline Flex Embolization Device with Flex Shield Technology
• Z-1527-2020 · Feb 14, 2020 · Terminated
  ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
• Z-0309-2017 · Oct 5, 2016 · Terminated
  Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled
• Z-0310-2017 · Oct 5, 2016 · Terminated
  X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 103-0602-350V09 103-0601-300V02 103-0602-300V01 10
• Z-0308-2017 · Oct 5, 2016 · Terminated
  Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No. FA-88810-20V04 FA-88810-20V06 FA-88810-30V04
• Z-0307-2017 · Oct 5, 2016 · Terminated
  Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 year of age or older) with large or giant widenecked intracrani
• Z-0120-2016 · Sep 4, 2015 · Terminated
  -Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices consist of a permanent implant combined with a guidewire based
• Z-1453-2014 · Apr 1, 2014 · Terminated
  Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.
• Z-2045-2013 · Jul 19, 2013 · Terminated
  Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-neck